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In a unanimous decision, the Supreme Court invalidated personalized medicine patents on grounds they are unpatentable subject matter under Section 101 of the Patent Act.

In a long-awaited decision addressing patentable subject matter, the Supreme Court invalidated patents directed to customizing methods of treatment. Mayo Collaborative Serv. v. Prometheus Labs, 566 U. S. ___ (2012). This was the second time in recent years that the Court opined on the scope of patentable subject matter under 35 U.S.C. § 101. See Bilski v. Kappos, 561 U.S. ___ (2010).

The patents at issue, U.S. Patent Nos. 6,355,623 and 6,680,302, pertained to methods of optimizing the therapeutic efficiency of thiopurine drugs in a patient suffering from an autoimmune disease. The Court’s analysis focused on claim 1 of the ‘623 patent because the “other claims in the patents do not differ significantly from claim 1.” Slip op. at 6. Claim 1 of the ‘623 recites as follows:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject; and wherein the level of 6-thioguanine greater than about 400 pmol per 8 x 108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject. ‘623 patent, col. 20, ll. 10-20 (emphasis added).

To reach its decision, the Court’s analysis began with the well-established exclusionary rule that “laws of nature, natural phenomena and abstract ideas’ are not patentable.” Mayo, slip op at. 1 quoting Diamond v. Diehr, 450 U.S. 175, 185 (1981). The Court determined that the claims were directed to processes reciting laws of nature and, therefore, unpatentable. Slip op. at 8. In doing so, the Court overruled the Federal Circuit, which held that claims “do not encompass laws of nature or preempt natural correlations.” See slip op. at 8.

The Court recognized that there must be some balance in the application of the exclusionary rule. “[T]oo broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.” Slip op at 2. Thus, “an application of a law of nature or mathematical formula to a known structure or process may be well deserving of patent protection.” Id. quoting Diehr, 450 U.S. at 187 (emphasis in original). However, “to transform an unpatentable law of nature into patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words.” Id. at 3 (emphasis in original).

To determine the patentability of the claims, the Supreme Court posed the question:

whether the claims do significantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?

Slip op. at 8. In answering the question “no,” the Court noted that process claims reciting a law of nature are not patentable unless the claim “has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” Slip op. at 9. Simply reciting the law of nature with instructions to “apply the law” is insufficient. Id.

The Court found that the claims at issue lacked such additional features. “The process that each claim recites tells doctors interested in the subject about the correlations that the researchers discovered.” Slip op. at 9. These correlations are specified in the “administering,” “determining” and “wherein” steps. These steps while “not themselves natural laws” were insufficient “to transform the nature of the claim” to render the claim patentable. Id. The “administering step” was insufficient because it merely refers to a specific audience – i.e. doctors treating patients with the drug. As the court noted, “the prohibition against patenting abstract ideas cannot be circumvented by attempting to limit the use of the formula to a particular environment.” Slip op. at 9 citing to Bilski, slip op. at 14. Similarly, the “wherein” steps were insufficient because they “tell a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating a patient.” Id. Since the “determining” step merely recites commonly practiced conventional activity by those in the field, it was also insufficient to impart patentability. Such “[p]urely ‘conventional or obvious’ ‘[pre]solution activity’ is normally not sufficient to transform an unpatenable law of nature into a patent eligible-application of such law.” Id. at 10, quoting Parker v. Flook, 437 U.S. 584, 590 (1978). Similarly, the combination of the three steps also was insufficient:

“the claims inform a relevant audience about certain laws of nature; any additional steps consist of wellunderstood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.” Id. at 11.

The Court also provided some guidance to patentable subject matter under Section 101. “[S]imply appending conventional steps, specified at a high level of generality to laws of nature, natural phenomena, and abstract ideas” does not render a claim patentable. Id. at 14. Integrating a mathematical formula, which alone would be unpatentable, into a process thereby “transform[ing] the process into an inventive application of the formula” is sufficient. Id. at 11. Similarly, process claims that contain both laws of nature and “several unconventional steps…that confine[] the claims to a particular, useful application of the principle” are also patentable. Id. at 15. The Court rejected the argument that the claims were transformations and reductions of an article to a different state and also refused to carve out new rules of patentable subject matter for diagnostic laws of nature. Id. at 19.

Although many have asserted the decision creates a significant uncertainty as to whether personalized medicine methods are patentable, it is worth noting that the U.S. Patent Office has already issued interim guidelines on the decision. Interestingly, the PTO states that the examiners “should continue to examine patent applications for compliance with section 101 using the existing interim Bilski guidance factoring additional considerations” discussed in Prometheus.

According to these guidelines, patentable claims “are not directed to an exception to the eligibility such that the claim amounts to a monopoly on the law of nature, natural phenomenon, or abstract idea itself.” PTO Interim Guidelines at 2 (emphasis in original). Patentable claims “amount to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.” Id. (emphasis in original). Claims drawn to an exception under 101 (i.e. laws of natural, natural phenomena or abstract ideas) should be rejected as being directed to non-statutory subject matter. Id. at 2-3. In response to such a rejection, applicants should explain why the claims are “not drawn solely to the exception and point to the limitations in the claim that apply the law of nature, natural phenomena or abstract idea.” Id. at 3. The PTO is in the process of developing further detailed guidance on patentable subject matter under Section 101. Id.

In a subsequent decision, the Court vacated the judgment in Association for Molecular Pathology v. Myriad Genetics, Inc. and remanded the case to the Federal Circuit for further consideration in light of Mayo. The Myriad case was pending in the Supreme Court to address the patentability of DNA-based inventions. Recently the District Court for the District of Columbia invalidated a patent claiming a system and method to guide the selection of therapeutic treatments using a computer program relying on Prometheus.See SmartGene v. Advanced Biological Laboratories, No. 1:08-CV-0642 (BAH), 2012 WL 1059611, ___ F. Supp. 2d ___ (D.D.C., March 30, 2012).